510(k) · Cleared
ClearedHeinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hg Innovations, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 20, 2023 as substantially equivalent to K110924 (Synergetics, Inc., 2011) and 1 other predicate after a 52-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Nov 20, 2023
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K884656 (1988). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
- 5 generations backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
- 4 generations backK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · Recalled
- 3 generations backK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · Recalled
- 2 generations backK162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps…Medos International SARL · 2016
- 1 generation backK193587 Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH · 2020 · Recalled
- This deviceK233346 Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm…Hg Innovations, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884656 | Disposable Bipolar Cord and Bipolar Forcep | Dermacare | 1988 | 1 |
| −5 | K080187 | Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps | Olsen Medical | 2008 | 1 |
| −4 | K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps | Synergetics, Inc. | 2011 | 3 |
| −3 | K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps | Synergetics, Inc. | 2012 | 19 |
| −2 | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru… | Medos International SARL | 2016 | — |
| −1 | K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH | 2020 | 1 |
| 0 (this device) | K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with… | Hg Innovations, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110924 | Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSummary page 6…ate Trade Name: Synergetics Disposable Single Use Dual Irrigating Standard Bipolar Forceps Predicate 510(k): K110924 B) Predicate 2: Non-irrigating forceps Predicate Manufacturer: Sutter Medizintechnik GmbH Predicate Trade Name:… | 2011 |
| * | K193587 | Sutter Swyng non-stick bipolar forceps, single-useSummary page 6…icate Manufacturer: Sutter Medizintechnik GmbH Predicate Trade Name: Sutter Swyng® Nonstick Bipolar Forceps- Single Use Predicate 510(k): K193587 No reference devices were used in this submission. IV. DEVICE DESCRIPTION HG Innovations Ltd.’s electrical surgical instrument… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K110924.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300…
Read the full statement (204 words)
Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:
-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:
-ENT
-Gynecology
-Urology
-General Surgery
-Neurosurgery
-Laryngeal Surgery
-Orthopedic Surgery
-Thoracic Surgery
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.
HG Innovations, as a manufacturer, does not recommend a specific procedure.
Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233346: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233346
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026